MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-03-24 for BUSH URETERAL ILLUMINATING CATHETER SET N/A 084120 manufactured by Cook Inc.
[70770318]
(b)(4). Investigation - evaluation: a review of the dimensional verification, documentation, instructions for use (ifu), quality control and visual inspection of the returned device was conducted during the investigation. The device is shipped with an instruction for use (ifu). In the ifu it states: this catheter will not transmit thermal energy along its light fibers to patient tissue. Any excessive thermal damage from the light source will manifest at the catheter/light plug junction, and will not be transmitted along the catheter length. Note: start illumination with the light source at the lowest setting, as many light sources product thermal energy at varying temperatures. This will limit the possibility of thermal damage at the catheter/light plug junction. It is inadvisable to use any light source at its highest setting, unless the light source`s actual thermal energy output is known. The visual inspection of the returned device reported that the device had 1 plug and 2 catheters. The red ink mark catheter doesn? T have the teflon support sleeve. The length of the catheter measures 82 cm in length. The black ink mark catheter has the teflon support sleeve and measures 82. 5 cm in length. A visual examination noted that 8mm of the black ink mark fiber is melted into the support sleeve of the catheter. Both ends of the fiber plug assembly have a melted appearance and have pulled apart. The fiber appears melted. Both catheters were noticeably used. There is no evidence to suggest that the product was not made to specifications. Review of device history and non-conformances was not possible as the lot number was not available. A definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required. If the result of this investigation changes a follow up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[70770319]
It was reported by the user facility that a patient underwent an unspecified procedure using a bush ureteral illuminating catheter set. The attending physician indicated that after the procedure was completed the light fiber extensions were found to be split/snapped on both catheters above the bifurcation. There were no unintended sections of the device that remained inside of the patient? S body, nor did the patient experience any adverse effects due to this occurrence. The device has been returned and the visual inspection of the received device revealed that the ends were melted. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[73716372]
Corrected information (04/07/2017): date of awareness of the initial report was corrected from 03/06/2017 to 02/22/2017.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2017-00551 |
| MDR Report Key | 6431506 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-03-24 |
| Date of Report | 2017-03-24 |
| Date Mfgr Received | 2017-04-07 |
| Date Added to Maude | 2017-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUSH URETERAL ILLUMINATING CATHETER SET |
| Generic Name | FCS CATHETER, LIGHT, FIBEROPTIC, GLASS, URETERAL |
| Product Code | FCS |
| Date Received | 2017-03-24 |
| Model Number | N/A |
| Catalog Number | 084120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-24 |